Ireland
--:--IST
Recruiting Phase 3

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections

NCT05998187 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-04-15
Last updated
2026-01-22

Condition(s) studied

Fecal Incontinence

Investigational drug(s) / intervention(s)

intra-rectal botulinum toxin injections

intra-rectal botulinum toxin injections: Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.

Study summary

Previous studies have demonstrated the efficacy of this treatment in certain patients suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of action. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education) * Impairment of quality of life at investigator's discretion * Patients at least 18 years of age * Patients who have read and understood the information letter and signed the consent form * Patients affiliated to the French Social Security system * Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG urine pregnancy test at inclusion and for the duration of the study. * Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit) Exclusion Criteria: General * Pregnant women, women in labor, breastfeeding women, or women without proven contraception * Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship) * Exclusive passive fecal incontinence * Patient suffering from constipation (Rome IV criteria) * Patient with an evolving inflammatory or cancerous digestive pathology * Previous rectal surgery * Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit Linked to botulinum toxin injections * Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride) * Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.) * Presence of infection at injection site(s) * General anesthesia less than one month ago * Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects) * History of neurogenic damage such as polyradiculoneuritis * History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis * Botulinum toxin injections in the 3 months preceding the study * Clinical anal examination suggestive of anorectal abscess * Recent history (\<12 months) of myocardial infarction and/or rhythm disorders not reduced by appropriate treatment * Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders * Current treatment with anticoagulants or anti-aggregants or haemostasis disorders according to recommendations (SFED). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed depends on the type of anticoagulation and the patient's thrombo-embolic risk: * Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk will not be included. * Patients on anticoagulant or anti-aggregant therapy with a moderate or low thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist, treatment will be continued provided that the INR is within the usual range of 2 to 3 (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a short break and not take the AOD the evening before or the morning of the injections (GIHP, 2015). Linked to rectosigmoidoscopy * Local pathology preventing colonoscopy (anal stenosis) * Allergy or hypersensitivity to silicone and/or latex Linked to laxatives * Contraindication to DULCOLAX® 5 mg, gastro-resistant coated tablet * Contraindication to XIMEPEG®, powder for oral solution Linked to high-resolution manometry * Clinically diagnosed intestinal obstruction * Severe coagulopathy or oral anticoagulants * Cardiac disorders for which vagal stimulation is poorly tolerated

Primary outcome measure(s)

  • high amplitude propagative contractions — before and 1 month after intrarectal botulinum toxin injections.
    The primary endpoint is the time to onset of high amplitude propagative contractions (HAPC) after instillation of DULCOLAX® in the sigmoid and rectum, before and 1 month after intrarectal botulinum toxin injections.

Trial sites (1)

FacilityCityRegionStatus
Univesity Hospital, Rouen Rouen France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05998187 on ClinicalTrials.gov ↗ ← All trials in France